How To Minimize Risks "as far as possible" in MedTech

The MDR (Medical Device Regulation) explicitly requires in Annex I that medical device manufacturers must minimize risks "as far as possible".

But what does this truly mean?

• At what point is "as far as possible" achieved?

• Where does the boundary of "possible" lie?

• Can reducing risks "as far as possible" be considered economically feasible?

Does this requirement imply that every conceivable measure must be taken to minimize both the occurrence and severity of damage?

Key Topics Discussed in This Post:

• Where is the Limit of Minimizing Risks "as far as possible"? How to solve the problem?

• Defining "Minimizing Risks 'as far as possible'"

• Conclusion

Where is the Limit of Minimizing Risks "as far as possible"?

In this context, the MDR specifies (Annex I, Chapter I, paragraphs 1 and 2) that manufacturers should take into account:

• the "generally acknowledged state of the art", and

• that the benefit-risk ratio should not be negatively influenced.

So, we can assume that risks are minimized "as far as possible" when mitigation measures align with the "generally acknowledged state of the art". But what does this term encompass?

Defining "Minimizing Risks 'as far as possible'"

Unfortunately, there is no universally binding definition of the "generally acknowledged state of the art."

However, EN ISO 14971:2019 defines the "state of the art" as "generally accepted good practice in technology and medicine."

This indicates that the "generally acknowledged state of the art" does not necessarily represent the most advanced technical solution.

Instead, it reflects:

• Current applicable norms,

• Industry standards,

• Statutory limits, and

• Industry standards recognized at the time.

Conclusion: "Minimizing risks as far as possible"

We can therefore assume that risks have been minimized "as far as possible", if manufacturers implement mitigation measures that align with current norms, standards, and good practices within the medical device industry.

It is not required that experimental or cutting-edge technology are used to minimize risk "as far as possible".

The focus remains on applying practical, well-established measures that are recognized within the "generally acknowledged state of the art."

By adhering to these principles, manufacturers can effectively minimize risks while balancing practicality, feasibility, and regulatory requirements.

Author: Bernhard Lindner, MSc

Do you want to learn more about risk analysis or how best to approach this topic in your company? Then contact us today!

Our Risk Management experts will be happy to advise you.

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Further helpful links & resources:

SIFo Medical YouTube Channel: Short, valuable videos on Quality Management

MedTech Free Resources: Get free access to checklists & templates

TMV Guide: Your practical guide to perform test method validation (incl. templates & videos)